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The Pharmacokinetics and Effectiveness of Local LevoBupivacaine Injection on Primary Total Joint Replacement Model.

Primary Purpose

Arthropathy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Levobupivacaine Hydrochloride
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy focused on measuring Local analgesia, Pharmacokinetics, Total joint replacement

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Primary total joint replacement, no previous open surgery on the same joint
  2. Age 50~80 y/o, Pre-operative diagnosis: degenerative osteoarthritis
  3. Pre-operative deformity: varus <15°, valgus <15°, flexion contracture <15°.
  4. Patients with normal heart function
  5. Willing to receive post-operative questionnaire and outpatient clinic follow-up

Exclusion Criteria:

  1. Allergy to Patient-Controlled Analgesia or LevoBupivacaine
  2. Mental or cognitive illness that couldn't well response to questionnaire
  3. American Society Anesthesiologist more than III degree
  4. Liver cirrhosis, chronic renal insufficiency, heart disease or arrhythmia, insulin-dependent diabetes mellitus, and previous narcotic abuse history.
  5. Not suitable for using patient-controlled analgesia pump by evaluation of anesthesiologist

Sites / Locations

  • Chang Gung Memorial Hospital, Linkou

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Patient-Controlled Analgesia

Peri-articular LevoBupivacaine

Intra-articular LevoBupivacaine

Arm Description

Patient had no local analgesic agent during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.

Patient had periarticular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.

Patient had intra-articular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.

Outcomes

Primary Outcome Measures

Dosage of analgesic opioid agent
The total dosage of opioid agent after local LevoBupivacaine injection

Secondary Outcome Measures

Blood concentration of LevoBupivacaine
Venous return of local LevoBupivacaine could cause the difference of blood concentration

Full Information

First Posted
August 16, 2017
Last Updated
January 29, 2018
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03258697
Brief Title
The Pharmacokinetics and Effectiveness of Local LevoBupivacaine Injection on Primary Total Joint Replacement Model.
Official Title
The Pharmacokinetics and Effectiveness of Different Methods of Local LevoBupivacaine Injection, a Prospective Randomized Case Control Clinical Study on Primary Total Joint Replacement Model.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Total joint replacement is an ideal procedure to treat end stage joint disease. Good post-op pain relief could accelerate patient recovery and rehabilitation, and decrease admission days and medical cost. Local injection of LevoBupivacaine is an effective method in post-operative pain control. The effectiveness of local analgesia was noticed clinically. However, thorough studies about the pharmacokinetics of LevoBupivacaine, maintenance of effect, influence of post-operative rehabilitation are not well studied in different way of injection. The purpose of this study is to evaluate and analyze the pharmacokinetics and effect of local Levobupivacaine injection in different ways, the amount of post-operative fentanyl requirement after local injection, time to first fentanyl request, pain score, immediate post-operative function, side effect of analgesic agents, and medical cost, and to improve the quality of total joint replacement post-operative care.
Detailed Description
Single large dose of LevoBupivacaine had been proved good analgesic effect in total joint replacement surgery. However, the safety was not well studied. For better understanding the effect and safety of local analgesic agent, we choose LevoBupivacaine with different injection way to find out. We divide patient to three groups, for comparing the effectiveness of LevoBupivacaine, and safety of LevoBupivacaine by checking intra-blood concentration. The pre-emptive analgesics and post-operative analgesics were the same as routine protocol in other total joint replacement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy
Keywords
Local analgesia, Pharmacokinetics, Total joint replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient-Controlled Analgesia
Arm Type
No Intervention
Arm Description
Patient had no local analgesic agent during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.
Arm Title
Peri-articular LevoBupivacaine
Arm Type
Active Comparator
Arm Description
Patient had periarticular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.
Arm Title
Intra-articular LevoBupivacaine
Arm Type
Experimental
Arm Description
Patient had intra-articular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine Hydrochloride
Other Intervention Name(s)
Chirocaine
Intervention Description
Different way of LevoBupivacaine injection
Primary Outcome Measure Information:
Title
Dosage of analgesic opioid agent
Description
The total dosage of opioid agent after local LevoBupivacaine injection
Time Frame
post-operative day2
Secondary Outcome Measure Information:
Title
Blood concentration of LevoBupivacaine
Description
Venous return of local LevoBupivacaine could cause the difference of blood concentration
Time Frame
25min, 90min, and coming morning after LevoBupivacaine injection
Other Pre-specified Outcome Measures:
Title
Functional score
Description
The difference of functional score
Time Frame
Baseline, Post-operative day1, day2, week2, week6, week12, week24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary total joint replacement, no previous open surgery on the same joint Age 50~80 y/o, Pre-operative diagnosis: degenerative osteoarthritis Pre-operative deformity: varus <15°, valgus <15°, flexion contracture <15°. Patients with normal heart function Willing to receive post-operative questionnaire and outpatient clinic follow-up Exclusion Criteria: Allergy to Patient-Controlled Analgesia or LevoBupivacaine Mental or cognitive illness that couldn't well response to questionnaire American Society Anesthesiologist more than III degree Liver cirrhosis, chronic renal insufficiency, heart disease or arrhythmia, insulin-dependent diabetes mellitus, and previous narcotic abuse history. Not suitable for using patient-controlled analgesia pump by evaluation of anesthesiologist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Chen Lo, M.S.
Organizational Affiliation
Chang Gung Memorial Hospital, Linkou, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25158837
Citation
Chen CC, Yang CC, Hu CC, Shih HN, Chang YH, Hsieh PH. Acupuncture for pain relief after total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):31-6. doi: 10.1097/AAP.0000000000000138.
Results Reference
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PubMed Identifier
24439998
Citation
Chen DW, Hu CC, Chang YH, Lee MS, Chang CJ, Hsieh PH. Intra-articular bupivacaine reduces postoperative pain and meperidine use after total hip arthroplasty: a randomized, double-blind study. J Arthroplasty. 2014 Dec;29(12):2457-61. doi: 10.1016/j.arth.2013.12.021. Epub 2013 Dec 19.
Results Reference
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PubMed Identifier
17823012
Citation
Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.
Results Reference
background
PubMed Identifier
2310449
Citation
Wasudev G, Smith BE, Limbird TJ. Blood levels of bupivacaine after arthroscopy of the knee joint. Arthroscopy. 1990;6(1):40-2. doi: 10.1016/0749-8063(90)90095-u.
Results Reference
background
PubMed Identifier
3381989
Citation
Meinig RP, Holtgrewe JL, Wiedel JD, Christie DB, Kestin KJ. Plasma bupivacaine levels following single dose intraarticular instillation for arthroscopy. Am J Sports Med. 1988 May-Jun;16(3):295-300. doi: 10.1177/036354658801600317.
Results Reference
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The Pharmacokinetics and Effectiveness of Local LevoBupivacaine Injection on Primary Total Joint Replacement Model.

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